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High-alert therapy area: The JAK inhibitor class has undergone major safety label changes post-ORAL Surveillance, creating significant risk around pre-2022 promotional materials and safety claim comparisons. Biosimilar vs originator claims and indication creep across RA, PsA and AS are among the most litigated issues at the PMCPA in this space.
Comparative claims between adalimumab biosimilars and Humira, or between etanercept biosimilars and Enbrel, require careful attention to the distinction between bioequivalence and clinical superiority. Claims of advantage without robust data are regularly challenged.
Post-ORAL Surveillance updates to JAK inhibitor labels covering cardiovascular risk, malignancy and thrombosis require all promotional materials to be reviewed and updated. Continuing to use pre-2022 safety comparisons creates serious ABPI Code and regulatory risk.
Promotional materials for products approved in RA that imply, suggest or facilitate use in psoriatic arthritis or axial spondyloarthritis without that specific licence are a persistent compliance risk, particularly given the overlapping biologic prescribing population.
Claims that a specific biologic or JAK inhibitor is the preferred agent for a treat-to-target strategy, or that it achieves remission targets more effectively than alternatives, require head-to-head data or very careful qualification.
Patient registry and outcomes tracking programmes associated with biologics and JAK inhibitors must not cross into promotion. The PMCPA has found that data collection activities which incentivise prescribing constitute indirect promotion.
Citing EULAR guidelines in promotional materials to imply a preferred positioning for a product, or to associate a product with guideline recommendations that do not specifically name it, is a source of competitor complaints in rheumatology.
Built specifically for pharma teams working in immunology and rheumatology — not generic compliance content repurposed for your therapy area.
The pack includes expert walkthroughs of all relevant PMCPA adjudications in immunology and rheumatology. Here are three landmark cases.
The pack includes all relevant immunology & rheumatology PMCPA cases with video walkthroughs, expert commentary and quiz questions.
MSLs and medical advisors presenting biologic and JAK inhibitor data across rheumatology, gastroenterology and dermatology, where biosimilar and indication questions arise regularly
Sales specialists and brand managers for TNF inhibitors, JAK inhibitors and IL-17/23 biologics — including teams managing biosimilar entry and originator defence campaigns
Teams promoting biosimilar versions of adalimumab, etanercept or other originator biologics, where comparative claims require precise qualification against equivalence (not superiority) data
Regulatory affairs and compliance officers reviewing immunology promotional materials for JAK safety language, biosimilar comparative claims and indication boundary statements
Speak to us about the Immunology & Rheumatology Compliance Pack. Tell us your team size and therapy area focus and we'll put together the right package.
Need more therapy areas? See all 12 therapy area packs →
PD-1/PD-L1, CDK4/6, PARP inhibitors. OS vs PFS claims, biomarker promotion and compassionate use.
All 2,000+ PMCPA cases. Video. Podcast. Quiz. 5 points per case. The only case library of its kind in the UK.
12 therapy area packs covering Respiratory, Oncology, Cardiovascular, CNS, Diabetes, Immunology, Infectious Diseases, Dermatology, Musculoskeletal, Ophthalmology and more.
One real case. One key lesson. Every week — free.